To treat patients suffering from CIPN during chemo therapy using accupunture therapy

Acupuncture as a modality of treatment for Chemotherapy-Induced Peripheral Neuropathy in Breast Cancer-A Phase 3 Randomized Controlled Trial (ABC-CIPN).

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/01/030480

Enrollment

104

Registered

2021-01-14

Start date

Unknown

Completion date

Unknown

Last updated

2024-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C509- Malignant neoplasm of breast of unspecified site

Interventions

Intervention1: Acupuncture Needles: Acupuncture as a modality of treatment for Chemotherapy-Induced Peripheral Neuropathy in Breast Cancer Intervention2: Acupuncture: Test Arm (Arm A) - acupuncture al

Eligibility

Inclusion criteria

Inclusion criteria: 1 Patients with non metastatic breast cancer who have been experiencing grade 1 or greater CIPN for more than 1 week after completion of paclitaxel based chemotherapy 2 Aged 18 or above 3 ECOG performance status 0–1 4 Ability to fill the self-reported questionnaire in any of the three languages (English, Hindi or Marathi). 5 Normal blood counts defined as per WHO standards Female: Hemoglobin: 12.0-15.5 grams/dL, TLC-4000-11000 and PLC-1.5 lakhs to4 lakhs.

Exclusion criteria

Exclusion criteria: 1 ECOG performance status 2 or above 2 Patients who have hyperalgesia or allodynia 3 Patients having pre-existing causes of peripheral neuropathy like diabetic neuropathy, CKD 4 Patients with bleeding disorders 5 Unstable cardiac disease or myocardial infarction within 6 months prior to study entry 6 Peripheral neuropathy caused by tumor infiltration or compression of spinal nerves or surgical trauma 7 Pregnancy or potential pregnancy and nursing 8 Active clinically significant uncontrolled infection 9 Prior use of acupuncture for CIPN within 6 months prior to study entry 10 Patients with uncontrolled major psychiatric disorders, such as major depression or psychosis, will not be eligible for this trial. Patients with a history of depression or anxiety who are stable on or off psychiatric medications will be eligible

Design outcomes

Primary

Measure	Time frame
1 Improvement in Quality of life To assess the quality of life of the patients at starting of therapy and at 8 weeks of therapy 2 Quality of Life Questionnaire Chemotherapy-induced Peripheral Neuropathy 20 (EORTC QLQ-CIPN20) which has been validated in local languages and would be made available to the patients. 3 The pain detect questionnaire 4 EORTC Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). Timepoint: 8 weeks 12 weeks and 6 months from randomisation	—

Measure

Time frame

1 Improvement in Quality of life To assess the quality of life of the patients at starting of therapy and at 8 weeks of therapy 2 Quality of Life Questionnaire Chemotherapy-induced Peripheral Neuropathy 20 (EORTC QLQ-CIPN20) which has been validated in local languages and would be made available to the patients. 3 The pain detect questionnaire 4 EORTC Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). Timepoint: 8 weeks 12 weeks and 6 months from randomisation

—

Secondary

Measure	Time frame
1 To assess the neuropathy symptoms at 12 weeks and 6 months to see the long lasting effects of acupuncture on peripheral neuropathy 2 To calculate number of patients completing the allocated sittings of acupuncture Timepoint: 8 weeks 12 weeks and 6 months from randomization	—

Countries

India

Contacts

Public ContactDr Dilip Vallalthol

Tata Memorial Center

nissiabraham61@gmail.com022-24176795

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 6, 2026